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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER CATHETER, PERIPHERAL, ATHERECTOMY

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THE SPECTRANETICS CORPORATION SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Model Number 420-159
Device Problem Material Split, Cut or Torn (4008)
Patient Problem Unintended Radiation Exposure (4565)
Event Date 01/05/2022
Event Type  malfunction  
Manufacturer Narrative
Patient's date of birth, age unk. Patient's gender unk. Patient's weight unk. Patient's ethnicity/race unk. Relevant tests/laboratory data unk. Other relevant history unk. The device was not returned, thus no investigation could be completed.
 
Event Description
A peripheral atherectomy procedure commenced to treat a severely calcified lesion in the patient's proximal common femoral artery. The physician chose to use a spectranetics turbo elite laser atherectomy catheter to treat the patient. The procedure was completed with no reported patient harm. However, upon removal of the turbo elite device from the patient's body, there was a shear/tear observed in the catheter. This event is being reported for unintended radiation exposure, potential for harm.
 
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Brand NameSPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER
Type of DeviceCATHETER, PERIPHERAL, ATHERECTOMY
Manufacturer (Section D)
THE SPECTRANETICS CORPORATION
9965 federal drive
colorado springs CO 80921
Manufacturer (Section G)
THE SPECTRANETICS CORPORATION
9965 federal drive
colorado springs CO 80921
Manufacturer Contact
barbara creel
9965 federal drive
colorado springs, CO 80921
MDR Report Key13344850
MDR Text Key290808491
Report Number1721279-2022-00013
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K170059
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/25/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number420-159
Device Catalogue Number420-159
Device Lot NumberFBH21K27A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/15/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/17/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/27/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/25/2022 Patient Sequence Number: 1
Treatment
0.014 GUIDE WIRE MANUFACTURER UNK.; 6F INTRODUCER SHEATH MANUFACTURER UNK.; GUIDE CATHETER MANUFACTURER AND SIZE UNK.; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.
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